Advanced Solid TumorsPhase 1/2NCT03065023
Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001)
A Phase 1/2 study testing MK-4621 in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 6 sites in 3 countries.
Trial summary
This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to evaluate the safety, tolerability, and anti-tumor activity of intratumoral (IT)/intralesional (IL) injections of MK-4621 (RGT100) in adult participants with selected advanced or recurrent tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MK-4621
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 25 Apr 2017to 18 May 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years
- Participants with histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom all standard treatments have been used or are not feasible and MK-4621 (RGT100) is a suitable treatment option and:
- For Group A: has cutaneous, sub-cutaneous (SC), or lymph node injectable tumors
- For Group B: has injectable liver tumors or liver metastases
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >3 months as assessed by the Investigator
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- Adequate organ function
- Negative serum pregnancy test within 2 weeks before first dose of study drug if the participant is a woman of childbearing potential. Participants and participant's partners of childbearing potential must agree to use birth control consistently and correctly during the study and for at least 6 months after the last study drug application.
- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and 1 separate injectable lesion with diameter ≥1 cm but <7 cm
- Ability to provide written informed consent before any study drug-related screening procedures being performed
Who cannot join
- Any tumor-directed therapy within 4 weeks before study treatment
- Treatment with investigational drugs within 4 weeks before study enrolment
- Systemic steroids at a dose of >10 mg of prednisolone, >2 mg of dexamethasone a day or equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing
- Participants with rapidly progressing disease (as determined by the Investigator)
- Ongoing immune-related adverse events (irAEs) and/or adverse events (AEs) ≥ grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
- Within 4 weeks of major surgery
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- Prior splenectomy
- Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy
- Primary or secondary immune deficiency
- Active allergy requiring systemic medication or active infections requiring anti-infectious therapy
- Seropositive (except after vaccination) for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry
- Dementia or altered mental status that would prohibit informed consent
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
- History of stroke, seizures, encephalitis, or multiple sclerosis
- Gastric ulcer or inflammatory bowel disease or Crohn's disease or ulcerative colitis in the last 6 months
- Active drug or alcohol abuse
- Pregnant or breast feeding
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Universitätsklinikum Carl Gustav Carus - Phase I Unit
Dresden
Universitätsklinikum Essen
Essen
National Center for Tumor Diseases
Heidelberg
Spain2 sites
START - Fundación Jiménez Díaz - Phase I Unit
Madrid
START - Hospital Universitario HM Sanchinarro - Phase I Unit
Madrid
United Kingdom1 site
University of Oxford Department of Oncology, Churchill Hospital
Oxford
About this study
Official title: A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects With Advanced or Recurrent Tumors
This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to evaluate the safety, tolerability, and anti-tumor activity of intratumoral (IT)/intralesional (IL) injections of MK-4621 (RGT100) in adult participants with selected advanced or recurrent tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- MK-4621
- Keywords
- Advanced tumor, Intratumoral injection, Intralesional injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4621Drug
Also called RGT100
IT/IL injection Fixed concentration of 0.2 mg/mL Starting dose: 0.2 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cutaenous lesions | Experimental | Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received escalating doses of MK-4621 via intratumoral (IT)/intralesional (IL) injection twice each week (Q2W) over a period of 4 weeks. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (up to approximately 2 years). Receives: Drug: MK-4621 |
| Group B: Liver lesions | Experimental | Participants with injectable liver tumors or liver metastases were to receive escalating doses of MK-4621 via intratumoral (IT)/intralesional (IL) injection once each week over a period of 4 weeks. Participants were to have been able to continue to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (up to approximately 2 years). (Group B was not started. Development will continue with new protocol.) Receives: Drug: MK-4621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria
An AE was defined as any untoward medical occurrence in a study participant administered study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of AE referred to the extent to which an AE affected the participants daily activities as assessed by the Investigator and was based on NCI CTCAE grades: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe or medically significant but not immediately life-threatening); Grade 4 (Life-threatening consequences); or Grade 5 (Death related to AE). The number of participants who experienced at least one treatment-related AE or laboratory abnormality are presented by severity.
Measured: Up to 90 days post last injection (Up to approximately 192 days)
Number of Participants Who Experienced a Serious Adverse Event (SAE)
A SAE was defined as any AE, regardless of dose, causality or expectedness, that:
- Resulted in death;
- Was life-threatening;
- Required inpatient hospitalization or prolonged existing inpatient hospitalization;
- Resulted in persistent or significant incapacity or disability;
- Was a congenital anomaly or birth defect; or
- Was any other medically important event.
Measured: Up to 90 days post last injection (Up to approximately 192 days)
Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a study participant administered a study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. The number of participants who discontinued study treatment due to a treatment-related AE is presented.
Measured: Up to last injection (Up to approximately 102 days)
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria
DLTs were assessed during the first treatment cycle (28 days) \& were defined as any drug-related toxicity that occurred during the 28-day DLT period and included:
- Non-hematologic toxicity grade ≥3 (except diarrhea, nausea, and vomiting unless lasting >3 days despite optimal supportive care);
- Confirmed (with a second measurement after 24 hours) non-hematologic appropriately graded laboratory findings of Grade ≥3 that were ≤ Grade 1 at baseline;
- Hematologic toxicity:
- Grade 4 neutropenia ≥5 days, or Grade 3 neutropenia with fever (fever is >38.4ºC)
- Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia lasting >7 days or with bleeding; and
- Any other toxicity assessed as related to MK-4621, and which, in the opinion of the Investigator and the Sponsor physician constituted a DLT.
The number of participants who experienced a DLT is presented by NCI CTCAE version 4.03 severity grade.
Measured: Cycle 1 (Up to approximately 28 days); Each cycle was 28 days.
Secondary outcomes (1)
Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
ORR was defined as the percentage of participants who had a Complete Response (CR) or a Partial Response. Per irRECIST, CR (irCR) was defined as the complete disappearance of all measurable and non-measurable lesions. Lymph nodes must also have decreased to <0 mm in short axis. And, per irRECIST, Partial Response (irPR) was defined as a decrease of ≥30% in total measured tumor burden (TMTB) relative to baseline. For this study, irRECIST was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced an irCR or irPR based on irRECIST is presented.
Measured: Up to 60 days post last injection (Up to approximately 162 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start25 Apr 2017
- Primary completion18 May 2018
- Study completion18 May 2018
Why it stopped: Group B not started for business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study was to be conducted in 2 groups: * Group A: participants with transdermally/transmucosally injectable tumors, and * Group B: participants with injectable liver tumors or liver metastases. However, Group B was not started.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065023
- Sponsor's protocol ID
- 4621-001
- Other IDs
- 2016-003028-22, RGT100-001, MK-4621-001, 2016
- Status last verified
- Jul 2019
- First submitted
- 10 Feb 2017
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Moreno V, Calvo E, Middleton MR, Barlesi F, Gaudy-Marqueste C, Italiano A, Romano E, Marabelle A, Chartash E, Dobrenkov K, Zhou H, Connors EC, Zhang Y, Wermke M. Treatment with a retinoic acid-inducible gene I (RIG-I) agonist as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: results from two phase 1 studies. Cancer Immunol Immunother. 2022 Dec;71(12):2985-2998. doi: 10.1007/s00262-022-03191-8. Epub 2022 May 21.
PubMed 35596791
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects With Advanced or Recurrent Tumors
- ClinicalTrials.gov ID
- NCT03065023
- Acronym / sponsor ID
- 4621-001
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced tumor, Intratumoral injection, Intralesional injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Group B not started for business reasons.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to evaluate the safety, tolerability, and anti-tumor activity of intratumoral (IT)/intralesional (IL) injections of MK-4621 (RGT100) in adult participants with selected advanced or recurrent tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was to be conducted in 2 groups: * Group A: participants with transdermally/transmucosally injectable tumors, and * Group B: participants with injectable liver tumors or liver metastases. However, Group B was not started.
| Arm | Type | Receives |
|---|---|---|
| Group A: Cutaenous lesions | Experimental | Drug: MK-4621Participants with transdermally/transmucosally injectable tumors including cutaneous, subcutaneous or lymph node injectable tumors received escalating doses of MK-4621 via intratumoral (IT)/intralesional (IL) injection twice each week (Q2W) over a period of 4 weeks. Participants may have continued to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (up to approximately 2 years). |
| Group B: Liver lesions | Experimental | Drug: MK-4621Participants with injectable liver tumors or liver metastases were to receive escalating doses of MK-4621 via intratumoral (IT)/intralesional (IL) injection once each week over a period of 4 weeks. Participants were to have been able to continue to receive study treatment beyond Cycle 1 for the remaining duration of the study as long as clinical benefit (no overt clinical progression or toxicity considered to be intolerable as per Investigator's assessment) was present (up to approximately 2 years). (Group B was not started. Development will continue with new protocol.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged ≥18 years
- Participants with histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom all standard treatments have been used or are not feasible and MK-4621 (RGT100) is a suitable treatment option and:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy >3 months as assessed by the Investigator
- Adequate organ function
Key exclusion criteria (18 listed)
- Any tumor-directed therapy within 4 weeks before study treatment
- Treatment with investigational drugs within 4 weeks before study enrolment
- Systemic steroids at a dose of >10 mg of prednisolone, >2 mg of dexamethasone a day or equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing
- Participants with rapidly progressing disease (as determined by the Investigator)
- Ongoing immune-related adverse events (irAEs) and/or adverse events (AEs) ≥ grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-4621Also: RGT100IT/IL injection Fixed concentration of 0.2 mg/mL Starting dose: 0.2 mg | Drug | Group A: Cutaenous lesions, Group B: Liver lesions |
Primary outcome
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria
Time frame: Up to 90 days post last injection (Up to approximately 192 days)
An AE was defined as any untoward medical occurrence in a study participant administered study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of AE referred to the extent to which an AE affected the participants daily activities as assessed by the Investigator and was based on NCI CTCAE grades: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe or medically significant but not immediately life-threatening); Grade 4 (Life-threatening consequences); or Grade 5 (Death related to AE). The number of participants who experienced at least one treatment-related AE or laboratory abnormality are presented by severity.
Number of Participants Who Experienced a Serious Adverse Event (SAE)
Time frame: Up to 90 days post last injection (Up to approximately 192 days)
A SAE was defined as any AE, regardless of dose, causality or expectedness, that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolonged existing inpatient hospitalization; * Resulted in persistent or significant incapacity or disability; * Was a congenital anomaly or birth defect; or * Was any other medically important event.
Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE)
Time frame: Up to last injection (Up to approximately 102 days)
An AE was defined as any untoward medical occurrence in a study participant administered a study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. The number of participants who discontinued study treatment due to a treatment-related AE is presented.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria
Time frame: Cycle 1 (Up to approximately 28 days); Each cycle was 28 days.
DLTs were assessed during the first treatment cycle (28 days) \& were defined as any drug-related toxicity that occurred during the 28-day DLT period and included: * Non-hematologic toxicity grade ≥3 (except diarrhea, nausea, and vomiting unless lasting >3 days despite optimal supportive care); * Confirmed (with a second measurement after 24 hours) non-hematologic appropriately graded laboratory findings of Grade ≥3 that were ≤ Grade 1 at baseline; * Hematologic toxicity: * Grade 4 neutropenia ≥5 days, or Grade 3 neutropenia with fever (fever is >38.4ºC) * Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia lasting >7 days or with bleeding; and * Any other toxicity assessed as related to MK-4621, and which, in the opinion of the Investigator and the Sponsor physician constituted a DLT. The number of participants who experienced a DLT is presented by NCI CTCAE version 4.03 severity grade.
1 secondary outcome
Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Time frame: Up to 60 days post last injection (Up to approximately 162 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35596791Moreno V, Calvo E, Middleton MR, Barlesi F, Gaudy-Marqueste C, Italiano A, Romano E, Marabelle A, Chartash E, Dobrenkov K, Zhou H, Connors EC, Zhang Y, Wermke M. Treatment with a retinoic acid-inducible gene I (RIG-I) agonist as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: results from two phase 1 studies. Cancer Immunol Immunother. 2022 Dec;71(12):2985-2998. doi: 10.1007/s00262-022-03191-8. Epub 2022 May 21.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-4621 in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria (time frame: Up to 90 days post last injection (Up to approximately 192 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03065023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.